Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
Drug: Antithymocyte Globulin
Procedure: Allogeneic Stem Cell Infusion
Drug: Filgrastim (G-CSF)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease|
- Number of Participants with Transplant Related Mortality [ Time Frame: Transplant to 100 days post transplant ] [ Designated as safety issue: Yes ]Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.
|Study Start Date:||July 2005|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + Fludarabine + Melphalan
Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes for one day; Fludarabine 33 mg/m^2 IV for 4 days; Melphalan 70 mg/m^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
800 mg/m^2 IV over 30 minutes on Day -7 (1 day)
Other Names:Drug: Fludarabine
33 mg/m^2 IV over 30 minutes Day -5 to Day -2 (4 days)
Other Names:Drug: Melphalan
70 mg/m^2 IV over 30 minutes on Day -3 to Day -2 (2 days)Drug: Antithymocyte Globulin
2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation.
If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant.
Other Names:Procedure: Allogeneic Stem Cell Infusion
Infusion of stem cells on Day 0.
Other Names:Drug: Tacrolimus
0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months.
Other Name: PrografDrug: Filgrastim (G-CSF)
Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.
Other Name: GranulDrug: Methotrexate
5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.
Other Name: MTX
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00385788
|Contact: Paolo Anderlini, MD||713-792-8750|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Paolo Anderlini, MD|
|Principal Investigator:||Paolo Anderlini, MD||M.D. Anderson Cancer Center|